NIAID Process and Analytical Support for Development of HIV Vaccines

Please see the attachment below for the solicitation.

The development of vaccines to prevent the spread of HIV infection is among the National Institute of Allergy and Infectious Diseases (NIAID) highest priorities. In addition, vaccines administered to infected individuals have potential for inducing immune control of the infectious agent. While advances in immunology and molecular biology continue to offer an expanding array of approaches for the development of new vaccines/products, there is limited capacity and expertise to move promising concepts through the development process. Translational development activities, which are needed to bridge this gap, appear to be especially limited and thus have influenced the pace at which basic research findings can be evaluated in the clinic. To bridge the gap in translational development, NIAID specifically proposes to support two key critical components: process development and analytical characterization activities. This award will provide targeted specialized expertise and facilities for process development or analytic characterization.

The NIAID anticipates awarding an Indefinite Delivery Indefinite Quantity (IDIQ) contract to one organization that meets the overall qualifications needed to fulfill the technical requirements of the solicitation.

The Contractor shall carry out, either directly or through subcontractors and/or consultants, tasks in the following areas:

• Coordination and Technical Support (Central Functions)
• Analytical Characterization and Method Development
• Process Development

These services are provided to investigators on a case-by-case basis for a wide variety of product candidates, rather than to advance a single product candidate through an entire preclinical development pathway. These services have helped investigators obtain critical data and products needed to acquire additional funding, gain prospective partnerships, fulfill regulatory requirements, and complete studies needed before entering clinical trials.

The Contractor shall provide NIAID with a wide range of capabilities that are required for the product development of proteins for evaluation in clinical trials as vaccines. These activities are initiated prior to filing an Investigational New Drug (IND) application and continue as part of product development during ongoing clinical trials (Phase 2 and 3 chemistry, manufacturing, and control (CMC) activities). Access to product development activities (manufacturing process development and optimization, analytical characterization and assay development) is intended to facilitate the advancement of potential HIV protein vaccines in Phase 1, 2, and 3 clinical trials.

The Government anticipates awarding a single Indefinite Delivery/Indefinite Quantity (ID/IQ) contract that provides a guaranteed minimum award to the organization or consortium that best meets the overall qualifications needed to fulfill the technical requirements of this solicitation. The contract awardee must be capable of carrying out Task Orders in each of the three Task Areas identified in the Statement of Work for the base contract at the time of the award.

Concurrent with award of the base contract, the Government intends to issue a Task Order award in Task Area 1, #001-1, Coordination and Technical Support (Central Functions). The Task Order award will be a cost-reimbursement, term (level of effort) type Task Order with a Base Period of 12 months and Options to extend the Task Order in 12-month increments for a total possible Period of Performance of seven years (if all options are exercised). The requirement will be the delivery of 2.3 Full Time Equivalents per year.

Additional Task Orders will be awarded in Task Area 2 (Analytical Characterization and Assay Development), and Task Area 3 (Process Development) subsequent to the award of the base contract. It is anticipated that these Task Orders will be non-severable, cost-reimbursement, completion type Task Orders and have variable Periods of Performance. The Government anticipates awarding 3 Task Orders per year between Task Areas 2 and 3 during the life of the contract.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about June 16, 2015, and may be accessed through FedBizOpps http://www.fedbizopps.gov/ and the NIAID Office of Acquisition (OA) Home Page at http://www.niaid.nih.gov/contract. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.

For this solicitation, the NIAID requires proposals to be submitted via two methods: (1) Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable.

For directions on using eCPS, go to the website https://ecps.niaid.nih.gov and then click on "How to Submit."